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Luxturna(voretigene neparvovec)
Luxturna (voretigene neparvovec) is a gene pharmaceutical. Voretigene neparvovec was first approved as Luxturna on 2017-12-19. It has been approved in Europe to treat leber congenital amaurosis and retinitis pigmentosa.
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Novartis Pharmaceuticals
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
eye diseasesD005128
hereditary congenital and neonatal diseases and abnormalitiesD009358
Trade Name
FDA
EMA
Luxturna
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Voretigene neparvovec
Tradename
Proper name
Company
Number
Date
Products
LuxturnaVoretigene NeparvovecSpark TherapeuticsA-125610 RX2017-12-19
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
luxturnaBiologic Licensing Application2019-12-04
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
voretigene neparvovec, Luxturna, Spark Therapeutics, Inc.
2024-12-19Orphan excl.
Patent Expiration
No data
ATC Codes
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01X: Other ophthalmologicals in atc
— S01XA: Other ophthalmologicals in atc
— S01XA27: Voretigene neparvovec
HCPCS
Code
Description
J3398
Injection, voretigene neparvovec-rzyl, 1 billion vector genomes
Clinical
Clinical Trials
6 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Leber congenital amaurosisD057130Orphanet_65H35.5211——3
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameVORETIGENE NEPARVOVEC
INNvoretigene neparvovec
Description
Voretigene neparvovec, sold under the brand name Luxturna, is a gene therapy medication for the treatment of Leber congenital amaurosis.
Classification
Gene
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL3707275
ChEBI ID—
PubChem CID—
DrugBankDB13932
UNII ID2SPI046IKD (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 1,370 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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7 adverse events reported
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